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510(k) K811081

Device
Medullary Canal Scrapers
Applicant
THE ANSPACH EFFORT, INC.
510(k) number
K811081
Product code
HTO
Decision
Substantially Equivalent (SESE)
Decision date
1981-04-29
Date received
1981-04-21
Regulation
888.4540
Classification name
Reamer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HTO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111437SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)Synthes (USA) Products, LLC2011-08-10
K042899SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONSSynthes (Usa)2005-03-16
K013527MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEMSynthes (Usa)2001-12-21
K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMSynthes (Usa)2000-06-12
K954915FLEXIBLE INTRAMEDULLARY REAMERZimmer, Inc.1995-12-28
K903248COMBINATION REAMEROnyx Medical Corp.1990-07-30
K885100MCCONNELL REAMER GUIDEMcconnell Orthopedic1989-01-13
K870845WARSAW ORTHOPEDIC POINTED REAMERWarsaw Orthopedic, Inc.1987-03-11
K862933ABC-1000 SMALL JOINT REAMERSInstrumentation Industries, Inc.1986-08-18
K832686MULTIPLE MANUAL SURGICAL INSTRUMENTSHirata Sangyo Co. USA, Inc.1983-10-14
K790996C.C.F. FEMORAL DEBRIDEMENT PROBEDepuy, Inc.1979-06-27
K790307FLEXIBLE REAMER, GUIDE WIRE SYSTEM3M Company1979-02-22
K770203HAND REAMERSDepuy, Inc.1977-02-08